News | September 16, 2025
Biocartis receives FDA approval for Idylla CDx MSI test
First fully automated, cartridge-based companion diagnostic test for colorectal cancer patients approved in the United States
First fully automated, cartridge-based companion diagnostic test for colorectal cancer patients approved in the United States
Under the terms of this agreement, Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
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Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
He will lead the final stages of work to commission the 54,000-square-foot facility and then lead ongoing operations at the site
Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors
Seymour is recognized as one of the foremost quality leaders in the pharmaceutical industry
Seymour is recognized as one of the foremost quality leaders in the pharmaceutical industry
Late-breaking data to be featured in an oral presentation at the American Association for Cancer Research (AACR) annual meeting on Monday, April 8 and highlighted as part of the official meeting press program
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